FDA.reportPublic FDA data

Blood Lipid Test Strip

Primary DI
06935740726986
Brand
Blood Lipid Test Strip
Company
Urit Medical Electronic Co., Ltd.
Model
PFS 30,10strips/vial×2/box
Published
2024-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CHHEnzymatic Esterase--Oxidase, Cholesterol
JGYColorimetric Method, Triglycerides
LBRLdl & Vldl Precipitation, Hdl
MRRSystem, Test, Low Density, Lipoprotein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHHEnzymatic Esterase--Oxidase, CholesterolClinical Chemistry1
JGYColorimetric Method, TriglyceridesClinical Chemistry1
LBRLdl & Vldl Precipitation, HdlClinical Chemistry1
MRRSystem, Test, Low Density, LipoproteinClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06935740726986PrimaryGS10
86935740726982Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06935740726986069357407269866935740726986
8693574072698286935740726982

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyte monitoring system IVD, home-useA collection of devices including a portable, electrically-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used together for the quantitative measurement of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. It is intended to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
653742429
Device count
20
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06935740751568Fully-Automated Urine Chemistry AnalyzerDxU 1800c,1 unit2026-06-26
06935740751575Urine Chemistry StripsDxU 11FA, 100 Strips/tube"2026-06-26
06935740751582Urinalysis ControlDxU 11,1×8 mL DxU 11 NO.I 1×8 mL DxU 11 NO.II 1×8 2026-06-26
06935740751599Detergent Ready to UseDxU,1×5L2026-06-26
06935740751605Maintenance AgentDxU,1×1L2026-06-26
06935740751612SG ControlDxU,Level 1: 1×8mL, Level 2: 1×8mL, Level 3: 1×8mL2026-06-26
06935740751629Color ControlDxU,Red: 1×8mL, Yellow: 1×8mL, Green: 1×8mL2026-06-26
06935740751636Turbidity ControlDxU,Level 1: 1×8mL, Level 2: 1×8mL2026-06-26
06935740751643SG CalibratorDxU,2×8mL2026-06-26
06935740751650Turbidity CalibratorDxU,2×8mL2026-06-26
06935740751667Mutiple Control for SGDxU,8mL/vial, 4 vials/box2026-06-26
06935740751674Detergent ConcentratedDxU,1×500mL2026-06-26
06935740725705Blood Lipid AnalyzerPFS-30,1 Set/box2026-06-03
06935740725712Blood Lipid AnalyzerPFS-30A,1 Set/box2026-06-03
06935740730655Uric Acid MeterURIT-10,1 Set/box2026-06-03
06935740730679Uric Acid MeterPA-11,1 Set/box2026-06-03
06935740730716Hemoglobin MeterPH-01,1 Set/box2026-06-03
06935740730723Hemoglobin MeterPH-01A,1 Set/box2026-06-03
06935740751773Urine StripsUrineRS-11-MA2026-06-03
06935740751780URINE REAGENT STRIPSURITEST 11G2026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816042016080FORAFORA CARE INC.CHH2026-06-24
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.CHH2026-06-03
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.LBR2026-06-03
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.JGY2026-06-03
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.MRR2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.CHH2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.LBR2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.JGY2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.MRR2026-06-03
00816042016387FORAFORA CARE INC.CHH2026-04-27
00850014861834heartscare Total Cholesterol Test Strip (10pcs/box)Hearts Bio, Inc.CHH2026-04-17
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.LBR2026-03-09
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.CHH2026-03-09
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.JGY2026-03-09
00682607690077Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.LBR2026-03-09
00682607690077Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.JGY2026-03-09
00682607690077Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.CHH2026-03-09
00682607690084Mission Cholesterol Control SolutionAcon Laboratories, Inc.CHH2026-03-09
00682607690084Mission Cholesterol Control SolutionAcon Laboratories, Inc.LBR2026-03-09
00682607690084Mission Cholesterol Control SolutionAcon Laboratories, Inc.JGY2026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.LBR2026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.CHH2026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.JGY2026-03-09
10682607690050Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.LBR2026-03-09
00682607690060Mission Cholesterol MeterAcon Laboratories, Inc.LBR2026-03-09
00682607690060Mission Cholesterol MeterAcon Laboratories, Inc.CHH2026-03-09
00682607690060Mission Cholesterol MeterAcon Laboratories, Inc.JGY2026-03-09
10682607690074Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.JGY2026-03-09
10682607690081Mission Cholesterol Control SolutionAcon Laboratories, Inc.LBR2026-03-09
10682607690098Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.CHH2026-03-09